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Days after Thanksgiving, the FDA approved Foundation Medicine’s comprehensive genetic test for evaluating cancer. The idea—and practice—of testing tumors for specific DNA or protein abnormalities is not new. Previously, the agency listed several dozen approved companion diagnostic tests; these earlier tools check one or a few molecules to inform the cancer subtype, prognosis, and likelihood of response to treatments.

The novelty of Foundation’s approach—like that of a few other companies leading the field of cancer diagnostics—is the scope of testing. These laboratories examine hundreds of genes by a method called next-generation sequencing (NGS). For a price of $5800, in two weeks’ time, Foundation reports on tumor mutation burden (TMB), microsatellite instability (MSI), and mutations in any of 324 genes that may indicate sensitivity—or resistance—to oncology drugs.

Since that approval, the Centers for Medicare and Medicaid (CMS) has been weighing if Medicare should pay for genetic testing in all patients with advanced cancers. Analysts expected a decision last week.

Most immediately, the CMS decision will affect coverage of Foundation’s assay. CMS may also determine coverage with evidence development for similar—and competing—molecular pathology tests offered by other commercial labs and hospitals that have applied to the FDA and registered in the NIH Genetic Testing Registry.

But the pending CMS decision isn’t about one biotech company or test.

In recent years, I’ve interviewed scientists from Caris Life Sciences, Foundation Medicine, Genomic Health, Guardant Health and Myriad Genetics. Each of these companies, among others, offers a distinct—and I think rigorous—approach to molecular cancer evaluation. Yet many doctors who request these tests, don’t appreciate the variance in quality and features among them. Some oncologists simply order what’s available at their medical center or hospital network.

What’s at issue is the right of all cancer patients—regardless of wealth—to obtain high-quality information about their conditions. Patients and their doctors rely on accurate results for choosing the right treatment. Without access to these tests, those whose cancers have mutations for which matched, precision oncology drugs are available are doomed to take old-style chemotherapy before they might even consider new options.

If Medicare says yes, as it should, it won’t create a monopoly for one company that stifles innovation elsewhere. Rather, it will assure payment for accurate diagnostic tests to guide better cancer care. The FDA’s involvement and regulation of molecular cancer testing, including genomic evaluation, is good for patients.

I think that comprehensive genomic testing should be available to all U.S. cancer patients for two general reasons: First, it can help individual patients. This information connects patients to medicines that may already been approved for their exact cancer form, are available in clinical trials, or might be obtained through the FDA’s compassionate use program. These matched precision oncology drugs are worth considering if they slow the cancer’s growth and relieve symptoms; in some patients they are life-saving.

Second, this information benefits all of us, as a society. It’s essential for research! The more careful and specific molecular pathology we collect about different forms of malignancy today, in patients of all demographics, along with prospective data about their responses to treatment, including no treatment or palliative care only, the greater the chances will be for future patients to not suffer or die prematurely from treatable disease.

Accurate diagnostic tests support, and otherwise undermine, all clinical cancer research. Consider ASCO’s TAPUR trial that links patients to precision oncology drugs based on molecular findings in their tumors; the outcomes in each “basket” depend on the quality of testing by which study participants are matched. The same goes for the NCI-MATCH study. It doesn’t matter if trials are traditional Phase 1, 2 or 3, innovative in design, or involve evidence drawn from “real-world” databases; if the cancer patients’ genomic information is erroneous, the conclusions will not hold, and the studies will be without value.

As things stand, many cancer patients don’t have the chance to try better, promising agents until after their disease has progressed while on standard treatment. For people with tumors for which effective therapy is available, there is reason to hold off on experimental medicines (but no reason, apart from costs, to hold off on genomic evaluation). For those with incurable advanced malignancies—such as metastatic pancreatic cancer, bile duct cancer, liver cancer, gastric cancer, head and neck cancer, breast cancer, prostate cancer, colon cancer, brain cancer and sarcoma—why not do the molecular testing?

In her awesome book, Everything Happens for a Reason, theology professor and author Kate Bowler recounts the day she learned that her seemingly lethal cancer might respond to a drug. She writes:

“Ninety percent of people with advanced colon cancer will receive chemotherapy and get their limited chance at life beyond five years. But there are two other options: I might be among the 7 percent of people who have a disorder in which cancer cells multiply beyond control so quickly…It is an automatic death sentence. Or I might be among the remaining 3 percent who have a variation in that disorder that opens them up to new treatments.”

Lo and behold, Bowler soon learns she’s among the lucky 3 percent. “I have the magic cancer!” she yelled, according to her book.

It’s no accident that Bowler’s academic oncologists in North Carolina determined she might be eligible for a trial of a new drug at Emory, in Atlanta. Her doctors knew to check for genomic changes soon after her diagnosis, and they did so. Unfortunately, many cancer patients don’t request these kinds of tests, and not all doctors offer them routinely.

The problem, of course, is money.

Not covering these tests serves insurers’ interests. These are expensive tests that will lead to more prescriptions of expensive drugs. And if the matched drugs do extend overall survival but are not curative, there’s the wonderful possibility that more cancer patients will survive and need treatment for a very long time.

Which leads to the subject of “stakeholders”– a term I despise, and likely pertains to why the CMS decision is taking so long. Should insurers pay for these tests, if these serve research purposes? Should the government? Need philanthropy take care of it? Perhaps Foundation Medicine needs cut its price, as should other precision oncology companies (see below) as their tests move forward in the FDA regulatory pathway.

Patients can’t be expected to pay for genomic cancer testing; already, they and their families are suffering from financial toxicity of cancer treatment costs, besides the experience of illness. The expense of evaluation will only exacerbate disparities in patients’ treatment options and, almost certainly, outcomes.

In context of a month’s worth of a typical cancer care costing between $10,000 and $20,000, an up-front test for $5800 may be prudent. And eventually, as more tests become available, economic competition may serve to lower prices. But the assays won’t be identical, in quality or scope; the cheapest assay may not be best for patients (or research). Besides, the U.S. experience with oncology drugs does not support that a free market cuts charges; there is no reason to expect an invisible hand will reduce costs of diagnostic pathology.

These tests are necessary, because progress is rapid. Consider advances in the past year. Just last June, I wrote about an experimental pill, larotrectinib, that targets a rare, cancer-driving genetic switch called a TRK fusion. Just last month, the NEJMupdated findings for that drug’s use in patients, including babies, with otherwise incurable, historically “bad” cancers, like sarcoma, in which a TRK fusion was found. So far, 75% of patients with the TRK marker have responded to this drug, some quite dramatically, and the drug is well-tolerated. The FDA is reviewing this drug for possible approval later this year.

In 2018, how could an oncologist not check for a TRK fusion or other molecular feature for which a matching drug is approved or otherwise available? I think oncologists have an ethical obligation to request genomic testing in a patient who seeks treatment for advanced cancer.

As precision oncology moves forward, the proportion of patients with actionable—clinically relevant, druggable—mutations is expanding. For most of a decade, oncologists have routinely checked for specific mutations in a few tumor types such as lung cancer and melanoma. But as the costs of genome sequencing falls, it makes no economic sense to order individual assays in a scattershot manner.

It’s only by routine testing everyone with stage 4 cancer that all patients can find out if they might benefit from a precision oncology drug. For instance, Keytruda has been approved and confers long-lasting remissions in a non-trivial fraction of cases with high MSI, a genomic finding. A woman with ovarian cancer should know if her malignancy has acquired BRCA-like changes, in which case an oral PARP inhibitor might keep the tumor in check for a long time. There are many examples.

Lawmakers and policy-makers have an obligation to sort through these issues, promptly. The American Cancer Society estimates that this year, nearly 610,000 Americans will die from cancer.

Patients should be demanding these tests. Because if you’ve got a cancer that’s going to kill you, you should find out if it’s a molecular match for a medication that might enable you to live longer, or at least relieve your symptoms.

Meanwhile insurance, public or private, should pay for it, and I mean all of it: the diagnostic evaluation and cancer treatment. Because that’s what insurance is for.

As a physician and lifelong patient, I advocate for universal access to modern and compassionate health care. Previously I worked as a blood and cancer specialist. Now…

As a physician and lifelong patient, I advocate for universal access to modern and compassionate health care. Previously I worked as a blood and cancer specialist. Now I'm writing a book on cancer attitudes.